- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04781764
The Study of Microglia/Macrophages Involved Dynamic Evolution of Glioma Microenvironment and the Function and Visualization of Targeted Molecules of Glioma
Studieoversikt
Detaljert beskrivelse
To collect tissue samples from different stages of glioma evolution and establish a high-quality high-throughput sequencing database of immune microenvironment cells, so as to lay a data foundation for later mining the dialogue mechanism and key targets between immune cells and tumor cells in glioma microenvironment.
Based on the analysis results of the above database, the key role of key target molecules in the dialogue between GIM and glioma cells and the regulation ability of immune cells in the immune microenvironment were confirmed through cell and mouse animal experiments, which laid the foundation for later targeted drug research and development.
Combined with fluorescence imaging technology, through in vivo imaging of mice, it can provide more intuitive and effective visual verification for the dynamic infiltration process of GIM and other immune microenvironment cells in the process of glioma evolution, and provide a new theoretical basis for the visualization research of dynamic regulation of glioma immune microenvironment cells.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
-
-
-
Shanghai, Kina, 200040
- Rekruttering
- Huashan Hospital,Fudan University
-
Ta kontakt med:
- Yu Yao
- Telefonnummer: 86-021-5288-9999
- E-post: yu_yao03@126.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled
- They were 18-80 years old, male and female;
- The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
- Tissue (6 mm * 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
- Sign informed consent.
Exclusion Criteria:
Patients who meet any of the following criteria will not be included in this study:
- Participants in other clinical trials;
- Pregnant women.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
glioma patients
glioma patients with routine surgery
|
kirurgi
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Multi-omics characteristics of glioma patients
Tidsramme: 24 month
|
we aim to describe patient's features about transcriptomics 、Immunomics、Radiomics ,etc.
|
24 month
|
|
expression level of protein,drived from paraffin-embedded specimens, retrospectively collected.
Tidsramme: 24 month
|
different expression level of proteins in Gliomas with different grades and molecular subgroups (500 cases)
|
24 month
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Chen DS, Mellman I. Oncology meets immunology: the cancer-immunity cycle. Immunity. 2013 Jul 25;39(1):1-10. doi: 10.1016/j.immuni.2013.07.012.
- Ostrom QT, Gittleman H, Farah P, Ondracek A, Chen Y, Wolinsky Y, Stroup NE, Kruchko C, Barnholtz-Sloan JS. CBTRUS statistical report: Primary brain and central nervous system tumors diagnosed in the United States in 2006-2010. Neuro Oncol. 2013 Nov;15 Suppl 2(Suppl 2):ii1-56. doi: 10.1093/neuonc/not151. No abstract available. Erratum In: Neuro Oncol. 2014 May;16(5):760.
- Ribas A, Wolchok JD. Cancer immunotherapy using checkpoint blockade. Science. 2018 Mar 23;359(6382):1350-1355. doi: 10.1126/science.aar4060. Epub 2018 Mar 22.
- Gotwals P, Cameron S, Cipolletta D, Cremasco V, Crystal A, Hewes B, Mueller B, Quaratino S, Sabatos-Peyton C, Petruzzelli L, Engelman JA, Dranoff G. Prospects for combining targeted and conventional cancer therapy with immunotherapy. Nat Rev Cancer. 2017 May;17(5):286-301. doi: 10.1038/nrc.2017.17. Epub 2017 Mar 24.
- Wicki A, Mandala M, Massi D, Taverna D, Tang H, Hemmings BA, Xue G. Acquired Resistance to Clinical Cancer Therapy: A Twist in Physiological Signaling. Physiol Rev. 2016 Jul;96(3):805-29. doi: 10.1152/physrev.00024.2015.
- Kim PS, Armstrong TD, Song H, Wolpoe ME, Weiss V, Manning EA, Huang LQ, Murata S, Sgouros G, Emens LA, Reilly RT, Jaffee EM. Antibody association with HER-2/neu-targeted vaccine enhances CD8 T cell responses in mice through Fc-mediated activation of DCs. J Clin Invest. 2008 May;118(5):1700-11. doi: 10.1172/JCI34333.
- Peng W, Chen JQ, Liu C, Malu S, Creasy C, Tetzlaff MT, Xu C, McKenzie JA, Zhang C, Liang X, Williams LJ, Deng W, Chen G, Mbofung R, Lazar AJ, Torres-Cabala CA, Cooper ZA, Chen PL, Tieu TN, Spranger S, Yu X, Bernatchez C, Forget MA, Haymaker C, Amaria R, McQuade JL, Glitza IC, Cascone T, Li HS, Kwong LN, Heffernan TP, Hu J, Bassett RL Jr, Bosenberg MW, Woodman SE, Overwijk WW, Lizee G, Roszik J, Gajewski TF, Wargo JA, Gershenwald JE, Radvanyi L, Davies MA, Hwu P. Loss of PTEN Promotes Resistance to T Cell-Mediated Immunotherapy. Cancer Discov. 2016 Feb;6(2):202-16. doi: 10.1158/2159-8290.CD-15-0283. Epub 2015 Dec 8.
- Syed Khaja AS, Toor SM, El Salhat H, Faour I, Ul Haq N, Ali BR, Elkord E. Preferential accumulation of regulatory T cells with highly immunosuppressive characteristics in breast tumor microenvironment. Oncotarget. 2017 May 16;8(20):33159-33171. doi: 10.18632/oncotarget.16565.
- Watters JJ, Schartner JM, Badie B. Microglia function in brain tumors. J Neurosci Res. 2005 Aug 1;81(3):447-55. doi: 10.1002/jnr.20485.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KY2020-009
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .